Medical Device Use Error Root Cause Analysis

Medical Device Use Error: Root Cause Analysis offers practical guidance on how to methodically discover and explain the root cause of a use error—a mistake—that occurs when someone uses a medical device. Covering medical devices used in the home and those used in clinical environments, the book presents informative case studies about the use errors (mistakes) that people make when using a medical device, the potential consequences, and design-based preventions. Using clear illustrations and simple narrative explanations, the text: Covers the fundamentals and language of root cause analysis and regulators’ expectations regarding the thorough analysis of use errors Describes how to identify use errors, interview users about use errors, and fix user interface design flaws that could induce use errors Reinforces the application of best practices in human factors engineering, including conducting both formative and summative usability tests Medical Device Use Error: Root Cause Analysis delineates a systematic method of analyzing medical device use errors. The book provides a valuable reference to human factors specialists, product development professionals, and others committed to making medical devices as safe and effective as possible.

Introduction Our Root Cause Analysis ProcessIntroductionStep 1: Define the Use ErrorStep 2: Identify Provisional Root CausesStep 3: Analyze Anecdotal EvidenceStep 4: Inspect Device for User Interface Design FlawsStep 5: Consider Other Contributing FactorsStep 6: Develop a Final HypothesisStep 7: Report the ResultsNext Steps The Regulatory Imperative to Perform Root Cause AnalysisFDA RegulationsEuropean Union RegulationsOther Regulators Applicable Standards and GuidelinesU.S. Food and Drug Administration (Silver Spring, Maryland USA)Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design, Issued on June 22, 2011International Standards Organization (Geneva, Switzerland)ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposesInternational Standard Organization (Geneva, Switzerland)ISO 14971:2007 Medical devices -- Application of risk management to medical devicesInternational Electrotechnical Commission (Geneva, Switzerland)IEC 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: UsabilityInternational Electrotechnical Commission (Geneva, Switzerland)IEC 62366-1:2015 Medical devices -- Part 1: Application of usability engineering to medical devicesSummary The Language of Risk and Root Cause AnalysisIntroductionRisk analysisHarmHazardHazardous situationIntended useUse errorLikelihoodSeverityRiskRisk evaluationRisk controlResidual risk Types of Use ErrorsPerception, Cognition, and Action ErrorsSlips, Lapses, and MistakesErrors of Commission and OmissionSafety-Related and Non-Safety-Related Use Errors Detecting Use ErrorsDetecting Use Errors during Usability TestsDetecting Use Errors during Clinical StudiesDetecting Use Errors during the Device’s Life Cycle Interviewing Users to Determine Root CausesIntroductionInterview TimingInterviewing Participants during Formative Usability TestsInterviewing Participants during Summative Usability TestsInterview Tips Perils of Blaming Users for Use ErrorsDon’t Blame the UserReporting Test Artifacts as a Root Cause of Use Error User Interface Design Flaws That Can Lead to Use ErrorIntroductionGeneral User Interface Design Flaw ExamplesHardware User Interface Design Flaw ExamplesSoftware User Interface Design Flaw ExamplesDocument User Interface Design Flaw ExamplesPackaging User Interface Design Flaw Examples Reporting Root Causes of Medical Device Use ErrorIntroductionResidual Risk AnalysisPresenting the Results of a Residual Risk Analysis Root Cause Analysis ExamplesAbout the root cause analysis examplesInsulin Pen InjectorDrug BottleAutomated External Defibrillator (AED)Handheld TonometerLancing DeviceTransdermal PatchElectronic Health Record (EHR)Syringe Infusion PumpSurgical Warming BlanketUrinary CatheterHemodialysis MachineUltrasonic NebulizerVentricular Assist Device (VAD)AutoinjectorStretcherSmartphone Application: Insulin Bolus CalculatorNaloxone Nasal SprayEnteral Feeding PumpMetered Dose InhalerDrug Patch PumpPatient MonitorJet NebulizerSyringeElectrosurgical Generator and HandpieceLarge-Volume Infusion PumpHospital BedPen InjectorBlood Gas AnalyzerDialysis Solution BagUltrasound Scanner Guide to Designing an Error-Resistant User InterfaceIntroductionPerceptionsText ReadabilityPushbutton FeedbackComponent VisibilityCognitionAction"Undo" ControlData EntryProtection against Inadvertent ActuationInstructional Content and FormatPackage Design Other Root Cause Analysis MethodsIntroductionThe 5 WhysIshikawa DiagrammingAcciMapThe Joint Commission’s Framework for Conducting a Root Cause AnalysisUPCARE ModelMatrix DiagramsCritical Decision Method (CDM)Systems-Theoretic Accident Model and Processes (STAMP)The Human Factors Analysis and Classification System (HFACS)Event Analysis for Systemic Teamwork (EAST) ResourcesBooksArticles and ReportsUS Food and Drug Administration (FDA) PublicationsStandardsWebsites

Michael E. Wiklund is general manager of the human factors engineering (HFE) practice at UL-Wiklund, as well as professor of the practice at Tufts University, where he teaches courses on HFE. He has more than 30 years of experience in HFE, much of which has focused on medical technology development. His work has involved optimizing the safety, effectiveness, usability, and appeal of various products. Widely published, he is a certified human factors professional and one of the primary contributors to today’s most pertinent guidelines on the HFE of medical devices: AAMI HE75 and IEC 62366. Andrea M. Dwyer is a managing human factors specialist at UL-Wiklund, where she leads some of the team’s most challenging user research and usability testing projects. She has authored numerous usability test reports that involve root cause analysis of medical device use errors. She also frequently composes usability engineering (i.e., human factors engineering, or HFE) program plans, administers usability tests, and develops HFE reports. She earned her BS in human factors engineering from Tufts University, where she received two prizes that honor achievement and excellence in human factors studies. She is currently a part-time graduate student in engineering management at Tufts University. Erin M. Davis is a managing human factors specialist at UL-Wiklund , where she develops and implements human factors engineering (HFE) programs and leads projects requiring expertise in user research, design, and usability testing of medical devices. She received her MS in HFE from Tufts University, and her BS in biomedical engineering from Marquette University. Erin is a published researcher and serves as the 2015 president of the Human Factors and Ergonomics Society’s New England chapter.